Cleared Traditional

K150628 - VentriPoint Medical System

K150628 is an FDA 510(k) clearance for VentriPoint Medical System, manufactured by Ventripoint, Inc.. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K150628 · Ventripoint, Inc. · Radiology device
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May 2015
Decision
72d
Days
Class 2
Risk

K150628 is an FDA 510(k) clearance for the VentriPoint Medical System. Classified as System, Imaging, Pulsed Doppler, Ultrasonic within the IYN classification (a category covering pulsed Doppler and ultrasound imaging systems), Class II - Special Controls.

Submitted by Ventripoint, Inc. (Bellevue, US). The FDA issued a Cleared decision on May 22, 2015 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1550 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ventripoint, Inc. devices

FDA 510(k) Submission Details - K150628

510(k) Number K150628 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 2015
Decision Date May 22, 2015
Days to Decision 72 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 107d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYN Device Classification - Class 2, Special Controls

Product Code IYN System, Imaging, Pulsed Doppler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1550
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - IYN System, Imaging, Pulsed Doppler, Ultrasonic

All 923
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K150628.
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